Method for surgical treatment of urinary incontinence and device for carrying out said method

Abstract

In a device and method for the percutaneous treatment of urinary stress incontinence in women using a synthetic sub-urethral tape, the device includes a needle, an intermediate traction element, and a sleeved support tape; and the method includes forming an opening in the vaginal wall and forming suprapubic incisions, creating tracks and following one track with a needle and intermediate traction element from a suprapubic incision to the opening in the vagina, following the other track with a needle and optionally an intermediate traction element, verifying the tracks by cystoscopy, passing a sleeved tape through the tracks to form a loop under the urethra, adjusting the loop, removing the sleeve, and leaving the tape implanted.

What is claimed is:  
     
       1. A method for treating urinary incontinence in a woman suffering from urinary stress incontinence, said method comprising at least the following steps: 
       a) forming an opening in the anterior vaginal wall;  
       b) forming two small suprapubic incisions in the abdominal wall, and creating a right track and a left track extending from the abdominal skin to the opening formed in the anterior vaginal wall, by penetrating from the abdominal skin to exit via the opening formed in the anterior vaginal wall;  
       c) using a needle and an intermediate traction element to follow one of the tracks from one of said small suprapubic incisions to the opening formed in the anterior vaginal wall, and following the other track with the needle and optionally an intermediate traction element;  
       d) verifying by cystoscopy that the path of these tracks is outside the bladder and the urethra;  
       e) using a support tape surrounded by a plastic sleeve to follow the tracks by passage under half of the inferior surface of the urethra;  
       f) adjusting the loop formed by the sleeved tape under the inferior surface of the urethra;  
       g) removing the sleeve by pulling towards the outside via the small abdominal incisions;  
       h) leaving the support tape implanted from the first to the second incision, going round the urethra and serving to support the urethra.  
     
     
       2. The method of  claim 1 , in which each track is produced using a needle inserted via the lower suprapubic incision and guided along the posterior surface of the pubis in contact with the finger of the surgeon introduced via the opening to the lower rim of the pubis on the same side. 
     
     
       3. The method of  claim 1 , in which the distal end of the tape is connected to the proximal end of the traction element after said verification. 
     
     
       4. The method of  claim 1 , in which the sleeve is cut in the central region. 
     
     
       5. The method of  claim 1 , in which the incision in the vaginal wall is T or I shaped. 
     
     
       6. The method of  claim 1 , in which vaginal detachment is carried out. 
     
     
       7. The method of  claim 1 , in which a urethral probe is first inserted. 
     
     
       8. A device for treating feminine urinary incontinence essentially constituted by: 
       a) a penetrating needle having a curved portion with an active distal end, which is integral with a straight portion having a proximal end;  
       b) a hermetically sleeved support tape having a distal end and a proximal end, the distal end being connected to the proximal end of the needle;  
       c) at least one intermediate traction element having a distal end connected to the proximal end of the needle and a proximal end which can be fixed to the distal end of the sleeved tape.  
     
     
       9. The device of  claim 8 , in which the cross section of the distal end of the needle is round and the cross section of the proximal end of the needle is substantially rectangular. 
     
     
       10. The device of  claim 8 , in which the sleeve of the tape is divisible at its centre. 
     
     
       11. The device of  claim 10 , in which the diameter of the distal end of the needle is about 0.5 mm and the cross section of the proximal end is about 2 mm×3 mm, the length of the proximal straight portion being about 20 cm. 
     
     
       12. The device of  claim 8 , in which the at least one traction element is at least one tube or lace. 
     
     
       13. The device of  claim 12 , in which the sleeve and/or at least one lace is (are) formed from a fluoropolymeric type material. 
     
     
       14. The device of  claim 12 , in which the tube is formed from PVC and its diameter is about 2.5 mm. 
     
     
       15. The device of  claim 8 , in which the tape is formed from a macroporous knitted material. 
     
     
       16. The device of  claim 8 , in which the tape comprises a hydrophilic non-stick film at its central portion. 
     
     
       17. The device of  claim 8 , in which the sleeve is formed from heat shrinkable material. 
     
     
       18. The device of  claim 8 , in which the straight portion of the penetrating needle has a ribbed surface over at least a portion thereof. 
     
     
       19. The device of  claim 8 , in which the needle and the traction element are screwed together to render them integral. 
     
     
       20. The device of  claim 8 , in which the traction element is constituted by two portions which are of substantially the same length, removably joined together. 
     
     
       21. The device of  claim 8 , in which a double male screw portion connects the two portions of the tubular traction element or one of its portions to the needle or to the tape. 
     
     
       22. The device of  claim 21 , in which the curved portion and the straight portion of the needle are screwed together to render them integral and removable.